Description
This guidance is intended to supplement FDA’s guidance for industry on Environmental Assessment of Human Drug and Biologics Applications, issued July 1998 (the EA Guidance), by addressing specific considerations for drugs that have potential estrogenic, androgenic, or thyroid hormone pathway activity (E, A, or T activity) in the environment. It is intended to help sponsors of such drugs determine whether they should submit environmental assessments (EAs) for drug applications and certain supplements, and to clarify what information such sponsors should include if they submit a claim of categorical exclusion instead of an EA.
Scope & Applicability
Product Classes
2drugs that block enzymes converting androgens into estrogens
drugs with potential E, A, or T activity
Stakeholders
1responsible for justifying omission of studies
Regulatory Context
Attributes
1drugs that have potential E, A, or T activity
Identified Hazards
Hazards
1potential to cause effects in the aquatic environment; potential harm to the aquatic environment
Related CFR Sections (5)
- 21CFR25.5§ 25.5 Terminology.
(a) Definitions that apply to the terms used in this part are set forth in the CEQ regulations under 40 CFR part 1508 . The terms and the sections of 40 CFR part 1508 in which they are defined follow:Read full regulation →
- 21CFR25.15§ 25.15 General procedures.
(a) All applications or petitions requesting agency action require the submission of an EA or a claim of categorical exclusion. A claim of categorical exclusion shall include a statement of compliance with the categorical exclusion criteria and shall state that to the applicant's knowledge, no extraRead full regulation →
- 21CFR25.21§ 25.21 Extraordinary circumstances.
As required under 40 CFR 1508.4 , FDA will require at least an EA for any specific action that ordinarily would be excluded if extraordinary circumstances indicate that the specific proposed action may significantly affect the quality of the human environment (see 40 CFR 1508.27 for examples of signRead full regulation →
- 21CFR25.31§ 25.31 Human drugs and biologics.
The classes of actions listed in this section are categorically excluded and, therefore, ordinarily do not require the preparation of an EA or an EIS:Read full regulation →
- 21CFR314.101§ 314.101 Filing an NDA and receiving an ANDA.
(a) Filing an NDA.Read full regulation →
See Also (8)
- Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products: Guidance for Industry (Status: Final)
- Guidance for Industry: Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to CFSAN (Status: Final)
- Environmental Assessment of Human Drug and Biologics Applications: Guidance for Industry (Status: Final)
- CVM GFI #221 Recommendations for Preparation and Submission of Animal Food Additive Petitions (Status: Final)
- CVM GFI #263 Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter (Status: Final)
- Over-the-Counter Monograph Order Requests: Format and Content (Status: Draft)
- CVM GFI #273 Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals (Status: Draft)
- CVM GFI #61 Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species (Status: Final)